LETTER OF MEDICAL NECESSITY



TEMPLATE LETTER OF MEDICAL NECESSITY: MCTProcal for Cystic Fibrosis (CF)DATE:PATIENT NAME: DOB:INSURANCE ID:GROUP #:SUBSCRIBER NAME:DIAGNOSIS CODE (ICD10): PROCEDURE CODE (HCPCS):To Whom It May Concern:[Patient Name] is a _____ year old patient diagnosed with an inherited disorder, Cystic Fibrosis with pancreatic insufficiency; [complicated by intestinal malabsorption, if applicable]. The purpose of this letter is to explain the medical necessity of Vitaflo MCTProcal and request insurance coverage for this medical care.Background Information: Cystic Fibrosis (CF) is a life-shortening, inherited disorder affecting the mucus-secreting glands of the body; especially the mucus in the bronchial tubes of the lungs and in the small ducts of the pancreas. This can lead to blockage in the lungs; and in turn infection and progressive lung damage. The pancreatic blockages can cause poor digestion and absorption of food, leading to inadequate growth and malnutrition. CF is strongly associated with poor nutritional status due to factors related to the underlying?genetic mutation, as well as other indirect factors such as higher energy needs, energy losses, and decreased?nutrient intake?and absorption. “In children and adults with CF, declining lung function is associated with decreasing nutritional status, leading to increased mortality. On the other hand, there is a clear link between good nutritional status and better lung function, which improves clinical outcomes and survival.” 1The Cystic Fibrosis Foundation recommends that individuals with CF [ages 20 years and younger, maintain a BMI at or above the 50th percentile on the Centers for Disease Control and Prevention (CDC) growth chart.] [ ages 21 and over, should maintain a BMI of at least (23 (men) | 22 (women)).] [Verify patient medical necessity for MCTProcal, including: HT/WT/BMI Growth chart/history of weight loss Current dietSupplemental enteral nutrition prescription (taken orally/via nasogastric tube/via gastric tube), if applicable Any pertinent lab results Medications Potential outcomes if MCTProcal were denied]I have prescribed MCTProcal to meet this patient’s specific nutritional needs. MCTProcal is a powdered medical food that contains Medium Chain Triglycerides (MCT), carbohydrate and protein. MCTs do not require pancreatic enzymes for digestion. Thus, they can provide an important source of supplemental calories in CF patients with exocrine pancreatic insufficiency; presenting with fat malabsorption and poor growth or nutritional status. MCTProcal can be administered orally or tube fed. It is not an over the counter product. MCTProcal is a medical food. A Medical Food as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." MCTProcal is classified as an Enteral Formula according to the Procedure Code (HCPCS Code). HCPCS Codes is B4155. NDC-Format Reimbursement Code is 50600-0502-36. It is manufactured for Vitaflo USA, LLC (Tax ID 14-1886053).Please approve coverage of this prescribed medical food/enteral formula for this patient’s inherited disorder. Consideration of this request is appreciated. Please contact me if you have additional questions.Sincerely, Name of PhysicianNPI# InstitutionContact InformationPossible Documents to Include: Detailed Written Order/Enteral Formula Prescription, Clinic Notes, Growth Chart, and LabsTurck D, et al. ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis. Clinical Nutrition. 2016; 35(3): 557-577. ................
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